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510(k) Data Aggregation
K Number
K042313Device Name
INTEGRADWEB MPR/MIP
Manufacturer
DYNAMIC IMAGING INC.
Date Cleared
2004-09-09
(14 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
DYNAMIC IMAGING INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
INTEGRADWeb MPR/MIP™ by Dynamic Imaging, Inc. is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Device Description
INTEGRADWeb MPR/MIP ™ is an Internet based software picture archiving and communications system that provides users with capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. INTEGRADWeb™ includes features to access and manage medical imaging studies from cat-scan (CT), magnetic radiography (MR), ultrasound (US), nuclear medicine (NM), computerized radiography (CR), digital radiography (DR), digital x-ray (DX), x-ray angiography (XA), PET scan (PT), and other imaging modalities. INTEGRADWeb MPR/MIP ™ is designed to be deployed over conventional TCP/IP networking infrastructure available in most healthcare organizations, and utilizes commercially available computer platforms (Intel Pentium-based) and operating systems (Microsoft Windows 2000, Windows NT, and Windows 98). The system does not produce any original medical images. All images located on INTEGRADWeb MPR/MIP ™ have been received from DICOM compliant modalities and/or systems.
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K Number
K031311Device Name
INTEGRADWEB BY DYNAMIC IMAGING, INC.
Manufacturer
DYNAMIC IMAGING INC.
Date Cleared
2003-06-20
(57 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
DYNAMIC IMAGING INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
INTEGRADWeb™ by Dynamic Imaging, Inc. is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Typical users of this system are trained professionals, as in physicians, nurses, and technicians.
Device Description
INTEGRADWeb™ is an Internet based software picture archiving and communications system that provides users with capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. INTEGRADWeb™ includes features to access and manage medical imaging studies from cat-scan (CT), magnetic radiography (MR), ultrasound (US), nuclear medicine (NM), computerized radiography (CR), digital radiography (DR), digital x-ray (DX), x-ray angiography (XA), PET scan (PT), and other imaging modalities. INTEGRADWeb™ is designed to be deployed over conventional TCP/IP networking infrastructure available in most healthcare organizations, and utilizes commercially available computer platforms (Intel Pentium-based) and operating systems (Microsoft Windows 2000, Windows NT, and Windows 98). The system does not produce any original medical images. All images located on INTEGRADWeb™ have been received from DICOM compliant modalities and/or systems.
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